Evidence based medicine study on prevention of postoperative recurrence and metastasis of non-small cell lung cancer with traditional Chinese Medicine

Phase 1

• Conditions: on small cell lung cancer

• Registration Number: ITMCTR2022000017
• Lead Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

? Postoperative patients with stage ii-iiia NSCLC diagnosed by pathology or cytology;
? Patients without tumor after adjuvant therapy were enrolled within 1 month after adjuvant therapy;
? The adjuvant chemotherapy regimen is the cycle of scheme 4 specified in NCCN guidelines
? Age 18-75 years old;
? Ecog0-1 for physical condition score;
? Estimated survival period = 6 months;
? The subjects had no dysfunction of major organs, normal blood routine, liver, kidney and heart functions, liver function: blood bilirubin = 2.0uln, blood alanine aminotransferase and glutamic oxaloacetic aminotransferase = 5uln; Renal function: serum creatinine = 2.0uln, blood urea nitrogen = 2.0uln; Bone marrow reserve: WBC = 3.0 × 109/l, absolute value of neutrophils (ANC) = 1.5 × 109/l, PLT = 80 × 109/l, hemoglobin (Hgb) = 80g/l.

Exclusion Criteria

? Preoperative neoadjuvant chemotherapy;
? Adenocarcinoma ex19del/l858r (+) patients
? In other clinical trials;
? Have a birth plan within one year and have been pregnant or breast-feeding patients;
? Those who cannot cooperate with the follow-up and are allergic to the study drug;
? Using immunotherapy or targeted therapy
? Any situation that may prevent the subjects from completing the follow-up process, including but not limited to severe and uncontrollable organic diseases or infections, unstable angina pectoris, congestive heart failure, etc; Severe liver and kidney dysfunction (serum creatinine = 1.5 times ULN; ALT or AST = 5 times ULN; bilirubin = 1.5 times ULN); Patients with nervous, mental disease or mental disorder accompanied by symptoms and difficult to control; The patients with central nervous metastasis whose condition is not controlled and who have obvious cranial hypertension or neuropsychiatric symptoms;

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DFS;

Secondary Outcome Measures

Name	Time	Method
TCM symptoms;Quality of Life;2-year DFS rate;Immune and inflammatory related indexes;1-year DFS rate;overall survival(OS);